Drug Shortages: Chronology
- Summary of Recent CPhA Efforts on Drug Shortages: CPhA works with government and key stakeholders to address the drug shortages issue
JUNE: The House of Commons Standing Committee on Health releases its report, Drug Supply in Canada: A Multistakeholder Responsibility.
APRIL: Dr. Jeff Poston, CPhA’s Executive Director, appears before the House of Commons Standing Committee on Health to address ongoing concerns regarding drug shortages, which are both “an access to care and a patient safety issue.” His six recommendations can be found in his speaking notes.
Centralized website made available. The Canadian Generic Pharmaceutical Association and Rx&D have centralized reporting on existing drug shortages to one website. Drug shortage information can now be accessed from www.drugshortages.ca. Additionally, they have invited non-member pharmaceutical companies to submit information on drug shortages, which will provide greater information to practitioners. Although this is a positive step forward in the evolution of reporting, the Drug Shortages Working Group, chaired by CPhA, is now working with GS1 Canada to implement a more robust reporting infrastructure, which will include such information as advice on clinical alternatives.
Jeff Morrison, CPhA's Director of Government Relations and Public Affairs, discusses drug shortages on an iPolitics live webcast with Dr John Haggie, President of the Canadian Medical Association, and others. “The notion of drug shortages may have come as a shock to many Canadians, but on April 13 at 10:30 a.m. iPolitics convened a panel of experts from the health industry for whom it was all too predictable.”
MARCH: The House of Commons has an emergency debate on drug shortages. CPhA is mentioned several times as a resource.
CPhA and the Canadian Society of Hospital Pharmacists (CSHP) send a joint letter to the federal Minister of Health requesting a meeting to discuss the current drug shortages situation involving Sandoz, but also to provide an update on drug shortages in general – including a request that Canada place this issue on the agenda of the World Health Organization.
HealthPro, MedPro and Sigma Sante write to Health Canada offering recommendations on how to address this situation – Richard Jones, CPhA Board Member representing hospital pharmacists, is intimately involved in that effort. CPhA also works with the American Pharmacists Association and FDA officials to better understand the workings of their drug shortages office (the FDA now has 11 full time staff working solely on drug shortages).
The Sandoz manufacturing production issues heighten concerns about drug supply, particularly in the hospital setting. CPhA continues to monitor and actively participate in efforts to address not just this particular situation, but drug shortages in general.
FEBRUARY: Sandoz, a multinational generic drug manufacturer, suspends production of several drugs at a Quebec plant following warnings from the US Food and Drug Administration (FDA). This places drug shortages in the media spotlight.
NOVEMBER: The short-term reporting system is put in place. The Working Group begins discussions on a longer-term permanent reporting system. The Working Group also commits to compiling a briefing paper that will recommend specific changes and reforms that Health Canada can take to address shortages and expedite supply to market. Three Liberal MPs host a roundtable on shortages, inviting several stakeholders to discuss the topic. CPhA hosts a webinar explaining the situation to members.
OCTOBER: The Minister responds favourably to reporting plan proposed in September. The Minister’s office releases the exchange of letters to media – several media outlets report the story.
SEPTEMBER: Letter to the Federal Minister of Health on Drug Shortages Working Group The eight-organization Working Group responds to the Minister with a two-fold plan. The Canadian Generic Pharmaceutical Association and Rx&D commit to collect information on shortages from their members. This information will then be posted publicly to the Saskatchewan Drug Information Service and vendredi.pm websites. At the same time, the group will look at a more robust, permanent solution, but will require more time to put this system in place.
AUGUST: Minister of Health writes the members of the Working Group, asking for a plan to report shortages by September 30, 2011. She also requests that the group continue to explore ways to mitigate shortages.
MAY: The two subcommittees exploring a drug supply monitoring system meet and plan activities. National and regional media report widespread oncology drug shortages. CPhA features prominently in the response, and the efforts on drug monitoring are highlighted and discussed in the national media.
APRIL: A meeting between drug manufacturers, wholesalers, CPhA, Canadian Medical Association (CMA), Canadian Association of Chain Drug Stores (CACDS) and Canadian Society for Hospital Pharmacists (CSHP) is held to discuss the Minister’s March letter. Preliminary agreement to begin discussions on a drug supply monitoring system is reached, and two subcommittees are created to move the effort forward for this Working Group.
MARCH: The Minister of Health sends a letter to drug manufacturers asking them to voluntarily submit information on shortages, and suggests that if they do not submit such information voluntarily, she will consider a regulatory option. Health Canada proposes changes to “notifiable changes” regulations that have delayed the approval of new drug manufacturing processes – this change is expected to expedite drug manufacturing processes, and is supported by CPhA.
FEBRUARY: On the second day that Parliament resumes, NDP Leader Jack Layton asks a question to the Minister of Health in the House of Commons regarding the government’s response to drug shortages. The Minister of Health reports she has met with CPhA and solutions are being examined. Additional media stories continue to highlight problems with drug shortages.
JANUARY: CPhA meets with the federal Minister of Health to discuss shortages and what role Health Canada can play to address them. CPhA sets up a coalition of like-minded stakeholders whose purpose is to share information and coordinate action on drug shortages. A first meeting is held.
DECEMBER: The results of the October survey are released publicly, along with a report that outlines suspected causes of shortages and recommendations on how shortages can best be addressed. The 427 respondents to the survey reveal that drug shortages are a widespread problem for pharmacists and that patient care has suffered as a result. The report results in widespread media attention, with stories appearing in the Globe and Mail, CBC, CTV, National Post, Radio Canada and numerous regional outlets.
OCTOBER-NOVEMBER: CPhA meets with associations representing generic and brand drug manufacturers, wholesalers and Health Canada to better understand the cause of drug shortages, and to discuss measures that can be taken to address shortages.
OCTOBER: CPhA issues a member survey on drug shortages, asking questions related to recent experiences with drug shortages, and what impact shortages are having on patient care.
SEPTEMBER: CPhA updates its 2004 document, Drug Shortages: A Guide for Assessment and Patient Management, and shares the updated guide with CPhA members.
JULY-AUGUST: CPhA hears an increasing number of anecdotal reports of drug shortages throughout Canada. Shortages are widespread and cover a range of medications.